Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04194515
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The investigators will evaluate the stool microbiota, serum and fecal bile acid composition, and changes in blood glucose and lipid profile before and after one month of metformin or YH1 treatment.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Metformin; YH1	Drug: YH1; Drug: metformin

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Metformin and YH1 in Patients With Treatment-naïve Type 2 Diabetes Mellitus: A Pilot Observational Study
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
YH1 group	Drug: YH1; YH1 treatment for one month
Metformin group	Drug: metformin; metformin treatment for one month

Outcome Measures

Primary Outcome Measures

1. bile acid profile [one month]

   before and after YH1 or metformin treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Treatment-naïve male patients with type 2 diabetes;

2. Aged 20-65 years;

3. Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) < 9 %;

5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month

Exclusion Criteria:

1. type 1,or other specific types of diabetes;

2. female;

3. history of oral hypoglycemic agents (OHAs) treatment or insulin therapy;

4. use of lipid-lowering drugs within the past six months;

5. serious gastrointestinal (GI) tract diseases, including peptic ulcers and GI tract bleeding;

6. hepatic insufficiency with ALT >72 U/L or renal insufficiency with an eGFR < 60 mL/min/1.73 m2;

7. history of stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, infectious disease, or surgery in the previous month;

8. mental illness;

9. current smoking status, alcohol or drug abuse;

10. hemoglobin disease or chronic anemia;

11. underlying conditions that could lead to poor compliance;

12. severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebrovascular disease;

13. continuous antibiotic or probiotics use for over 3 days within 3 months prior to enrollment;

14. continuous use of weight loss drug for over 1 month;

15. history of YH1 therapy, or Chinese medicine treatment within the past one month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04194515
• Other Study ID Numbers: 201901022A3C601
• First Posted: Dec 11, 2019
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gung Memorial Hospital: Bile acid; Microbiota
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin

Study Results

No Results Posted as of Jan 27, 2021